Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02169934
Eligibility Criteria:
Key Inclusion Criteria:
* Males, between 18 and 64 years of age, inclusive
* With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Negative test for selected drugs of abuse at Screening and at Check-in
* Able to comprehend and willing to sign an Informed Consent Form (ICF) prior to any study procedure
* A typical minimum of 1 to 2 bowel movements per day
Key Exclusion Criteria:
* History of sensitivity to any of the study medications or components thereof or a history of medication or other allergy that, in the opinion of the Investigator, contraindicates their participation
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 28 days prior to Check-in
* Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
* Has current malignancy, current systemic chemotherapy, or cancer diagnosis within 5 years prior to Screening (excluding squamous or basal cell carcinoma of the skin that has been clinically stable and fully excised in a curative procedure);
* Use of any tobacco- or nicotine-containing products within 6 months prior to Screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT02169934
Study Brief:
Protocol Section:
NCT02169934